Bothell, WA, United States
Solta Medical Inc recalls
2 recalls recorded since 2018, most recently on 16 February 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 February 2023
- Reason
- A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
- Distribution
- U.S. Distribution to state of: MD
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1354-2023
- thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasi
Terminated Class II Medical devices
- Recall started
- 30 December 2019
- Terminated
- 29 April 2024
- Reason
- Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
- Distribution
- US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1681-2020
- Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for el
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.